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    FDA’s December 2025 OPOE list features 784 prescription drugs, 73 OTC drugs

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    Pipeline Prospector 2025 highlights: FDA approves pill version of Novo’s Wegovy; BioMarin acquires Amicus for US$ 4.8 bn

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    Last Updated on PharmaCompass Virtual Booth Country Holder DMF No. Subject Submission Date Status Type GDUFA DMF Review GDUFA Review Date GDUFA Payment Date
    29/01/2026 Metrochem API Private Limited
    India
    		 METROCHEM API PRIVATE LTD 38089 VIGABATRIN USP 2023-06-14 Active II N/A
    29/01/2026 Granules India Limited
    India
    		 GRANULES INDIA LTD 35430 VIGABATRIN, USP 2020-12-29 Active II N/A
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